Validation of Virtual Reality Tests for the Assessment of Patients With Age-related Macular Degeneration as Clinical Endpoints

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorStreetlab

About this trial

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrialized countries and affects tens of millions of people worldwide, with a rapidly increasing prevalence. It causes irreversible central vision loss and significant difficulties in daily activities, impairing patients' quality of life and independence. Conventional clinical assessments, which focus on visual acuity and retinal imaging, do not fully reflect the functional impact of the disease.

Virtual reality (VR) makes it possible to create immersive, controlled environments to accurately measure functional vision and simulate real-life situations. The study proposes to develop a standardized and reproducible functional test in virtual reality that can complement conventional examinations and support clinical and industrial research.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 50 years

Sufficient knowledge of the French language

Ability to give personal, express, free, and informed consent

Ability to comply with the requirements of the protocol

Disqualifiers

Pregnant women, women in labor, or breastfeeding women

Subjects undergoing drug treatments that may cause motor, visual, vestibular, or cognitive disorders (PSA, neuroleptics, etc.) or that could interfere with the study examinations

Any concomitant intraocular condition in the eye being studied (e.g., glaucoma or cataract)

Any retinal pathology that could cause retinal atrophy other than AMD (eliminate dystrophy, chronic CRSC, pachyatrophy, resorption of vitelliform material with atrophy, high myopia, etc.)

Trial design

Design model

Single group

Treatments tested in this trial

  • Object recognition and selection task

    Other intervention

    The Sight Performance Object Task (SPOT) is a virtual reality (VR) based assessment designed to measure the object recognition and selection capabilities. It functional vision by replicating the real-world challenge of "finding things" under controlled environmental conditions.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: MainExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Net selection assessed by the SPOT test

Net selection is the number of selected targets, less the number of selected distractors

Time frame
Baseline
2

Number of Net selection assessed by the SPOT test

Net selection is the number of selected targets, less the number of selected distractors

Time frame
Hour 1
3

Number of target selection assessed by the SPOT test

Time frame
Baseline
4

Number of target selection assessed by the SPOT test

Time frame
Hour 1

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Streetlab

Lead sponsor

CIL - Centre Ophtalmologique d'Imagerie et de Laser

Collaborator

Fondation Ophtalmologique Adolphe de Rothschild

Collaborator

This trial is not recruiting at the moment. You can still explore other options: